(222 days)
Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine 25 ng/ml of Phencyclidine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the "Forsure One Step Multiple (Up to Six) Drug Screen Test Card":
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics. However, the implicit acceptance criteria are that the device is "substantially equivalent" to predicate devices (Monitect Multiple Drug Screen MOR2000/MET/THC/COC/PCP and GC/MS) for the qualitative determination of specific drugs at defined cut-off concentrations in human urine. The "reported device performance" is the claim of substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Qualitative determination of: | Forsure One Step Multiple Drug Screen Test Card |
| Amphetamine at 1000 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Methamphetamine at 1000 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| THC at 50 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Morphine at 2000 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Benzoylecgonine at 300 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Phencyclidine at 25 ng/ml cutoff | Claims substantial equivalence to predicate devices for qualitative determination at specified cutoffs. |
| Functioning as a rapid analytical screening procedure | Functioning as a rapid analytical screening procedure |
| Requiring a more specific alternate chemical method (like GC/MS) for confirmation | Explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not report specific sample sizes for a test set used to evaluate the Forsure One Step Multiple Drug Screen Test Card. It describes the device and claims substantial equivalence to predicate devices and GC/MS, implying that performance data was collected to justify this claim, but the details of such a study (sample size, data provenance like country of origin, retrospective/prospective) are not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The ground truth for confirming results is stated to be Gas Chromatography/Mass Spectrometry (GC/MS).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for a test set. This type of device relies on a chemical "ground truth" (GC/MS) rather than expert consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable to the described device. The Forsure One Step Multiple Drug Screen Test Card is a qualitative immunoassay device, not an AI-assisted diagnostic tool for which MRMC comparative effectiveness studies with human readers would typically be conducted. There is no mention of AI or human-in-the-loop assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of an immunoassay test with visual interpretation. The device's performance is inherently standalone in the sense that the test strip itself produces the result (presence/absence of a line), which is then visually interpreted. There is no complex algorithm involved in 'standalone' performance as understood in AI-driven diagnostics.
7. The Type of Ground Truth Used
The primary ground truth explicitly mentioned for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate analytical method used to identify and quantify substances in a sample, making it a robust reference standard for drug testing.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. As an immunoassay device, it does not involve machine learning or AI that would typically require a "training set" in the computational sense. The device's components and assays are developed based on chemical and biological principles, not statistical training data.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning, this question is not applicable. The underlying scientific principles and calibration of the immunoassay are established through chemical and biological validation, rather than a data-driven training process with established ground truth.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).